PREGART Clinical Trial Database Development Training for Project Staff Using REDCap Software - Shasmene, Ethiopia, April 26-29, 2021

A training course was held in Shasmene, Ethiopia, from the 26 to the 29 of April 2011 aimed to capacitate the research team and project staff on application of REDCap software on PREGART projects data entry and reporting so that the program will generate a high quality data for the project.

Main contents covered in the training were: Introduction to data, data quality, data quality dimensions; Introduction to REDCap software (Definitions, Important terminologies relevant to REDCap, REDCap features); Getting started with REDCap software; Creating New eCRF; Access & editing eCRF; Exporting data from REDCap to other Software.

Practical Session included: entering a fictitious data into the REDCap database; Identify limitations and errors in the CRFs created in the REDCap software; Identify data type as per the CRF; Save Data; Export Data variables; Edit and Save data dictionary (codebook).

Six project staff participated in the training: two trial site supervisors (one male and one female); two research team members; one clinical laboratory assistant; one project manager.

Download the presentation

 


The Covid -19 situation in Uganda and its impact on research activities

“The Uganda National Council of Science and Technology-UNCST” halted research activities on the 27th March, 2020. The halting included discouraging recruitment of new study participants due to the risk of infection the clinical teams and patients at the recruitment sites would have while conducting their activities. Researchers were also discouraged from inviting the already recruited participants to the health care facilities for follow up. Fortunately, this ban was lifted on 1st June, 2020 with UNCST putting strict guidelines for conducting research so as to ensure welfare and safety for both the research participants and the research teams. Overall, the research field was and is still greatly affected.

COVID-19 has greatly affected the world with over 100 million confirmed cases and over 2.5 million reported deaths worldwide. To date Uganda stands at over 40,000 confirmed cases and slightly over 300 deaths. It should be noted that as per the Centre for Disease Control and Prevention (CDC), the country is classed at level 4 (very high) for COVID-19 infections. Uganda registered her first COVID-19 case on 21st March 2020, this declaration coming just moments after the government had closed Uganda’s borders and banned international flights and water vessels from accessing the country, except for cargo and goods. The government also put in place more stringent measures like total lockdown of the country, restrictions on public transport, suspension of mass gatherings, curfew and closure of all public places including academic institutions, amongst others, to contain the spread of the virus to different parts of the country.

It is also worth mentioning that though COVID-19 is a health pandemic, it has had a disruptive socio-economic impact, with retardation in economic activity due to the measures put in place to try curb the spread of the virus. This has resulted in loss of jobs, reduced wages, increased poverty and a general desperation regarding livelihood for majority of the population, including researchers and possible study participants. This therefore raises concern regarding those taking part in the study, as they might be in situations where they need to devote more time to making ends meet, as opposed to taking part in the study, bringing into play a scenario where there is increased loss to follow-up and a great number of people dropping out of the study. Furthermore, due to this challenging economic situation, most people have migrated from urban areas, where the cost of living is relatively high, back to their rural homes to try cut down on costs of living. The result of this is possibly fewer study participants at recruitment sites, as these sites are in urban areas, thus putting a strain on the numbers enrolled as well as the planned timeline of studies.

With the onslaught of COVID-19 and its associated restrictions and SOPs, there has been a surge in costs of certain amenities and goods. Public transport costs have increased because by law carrier vehicles can only carry a restricted (half the usual) number of passengers; the transport providers have as a result doubled the price of transport fares to make up the difference. The hiking of these costs poses a financial challenge to studies as transport re-imbursement costs increase and need to be taken into account: also, fewer people might show up at the recruitment sites because of the expense of transport and this will lead to few enrollments and therefore slow down the research. As well, prices on the market for materials and gadgets necessary for preventing the spread of the virus, like PPE and hand sanitizer, have also soared as companies and businesses possibly try to make a profit from the situation: the studies must put infection prevention measures in place and this puts further financial strain on their budget and finances.

Though not clearly documented, there is also a mental health and psychosocial impact of COVID-19 on Ugandans with many healthcare workers reporting a rise in cases of stress, anxiety, depression and suicide, following the arrival of the pandemic and its associated imposed restrictions. Conducting research in a population with increased mental stress in an equally stressful environment is bound to produce unexpected situations and results, and therefore needs to be taken into consideration.

Although presently a lot of research and resources have gone into developing prevention and control measures, COVID-19 is still relatively novel and fast-evolving, and there are multiple knowledge gaps surrounding the understanding of its course, effective prevention, control and treatment measures, and this poses a fairly unpredictable future. More so, further impact of the disease on the country will depend on the response of the government, the international community, and quite importantly individuals in the community, in line with enforcing and maintaining observation of SOPs and other parameters put in place to reduce disease spread. It is thus vital to plan around and make room for this unpredictability and its possible effects on research as a whole.

 


Pregart Co-Principal Investigator, Professor Eleni Aklillu – winner of the Donald Mackay Medal

Professor Eleni Aklillu, Pregart Co-Principal Investigator and Professor in Tropical Pharmacology and research group leader at Department of Laboratory Medicine, has been awarded the prestigious RSTMH Donald Mackay Medal.

The medal is presented for outstanding work in tropical health and awarded annually by the Royal Society of Tropical Medicine and Hygiene (RSTMH) and the American Society of Tropical Medicine & Hygiene.

Eleni Aklillu is Professor in Tropical Pharmacology and research group leader at Karolinska Institutet, Stockholm, Sweden. She received a Bachelor of Pharmacy and MSc in Biochemistry from Addis Ababa University, and a PhD in molecular genetics from Karolinska Institutet. Her research focuses on clinical pharmacology and pharmacogenetics with special emphasis on how to optimize treatment and/or prevention of HIV, tuberculosis, malaria, and neglected tropical diseases. She investigated impacts of host-genetic factors, drug interactions, coinfections and comorbidities on drug safety and efficacy. Her research contributes to understanding treatment challenges and provide evidence-based recommendations to revise treatment guidelines and strategies.

Professor Aklillu has received several major external research grants as principal investigator and trained 20 PhD students from sub-Saharan Africa. She co-authored 130 peer-reviewed publications. Aklillu is a member of the Swedish research council committee for development research, a fellow of Royal College of Physicians Edinburgh and the African Academy of Sciences, and a former member of Strategic Advisory Committee for European and Developing Countries Clinical Trials Partnership (EDCTP).

“I am truly honored and delighted to receive the 2020 Donald Mackay Medal of Royal Society of Tropical Medicine and Hygiene. It is the result of our extensive clinical pharmacology research on the treatment of HIV, tuberculosis, malaria, and various neglected tropical diseases. It is encouraging and overwhelming to have my work recognized in this way, and I would like to acknowledge the hard work of everyone in my research group and my collaborators in Ethiopia, Kenya, Tanzania, Rwanda, Uganda, and Sweden during the last two decades” says Eleni Aklillu.

 


TRAINING FOR RESEARCH STAFF FROM PREGART TRIAL SITES IN UGANDA

PREGART project has successfully organized and conducted a 2-day Good Clinical Practice (GCP) training from 6th to 7th July 2020 and 1-day Protocol training on 8th July 2020 at Mildmay Hospital Lubowa. GCP training was offered by Mrs Mariam Nakitto and Dr. Balikuddembe Robert both GCP specialists from the Clinical Trials Unit, School of Public Health, Makerere University. The protocol training was offered by Dr. Jackson Mukonzo, Ugandan Country PI PREGART.
A total of 28 and 68 people was in attendance for the GCP and Protocol training respectively. These people were a representation of both the PREGART coordination office, Makerere University and the PREGART data collection site, the Mildmay Hospital.
A diverse expertise of fields was represented in both of these trainings spanning from nursing officers, medical officers, researchers, laboratory technologists and scientists, administrators, PhD fellows, gynaecologists, pharmacists, paediatricians and counsellors.
Both of these trainings in need equipped all participants in attendance with knowledge and skills on how to implement the PREGART clinical trial. However for in depth understanding of the protocol, an extended protocol training will be conducted at individual unit levels i.e. specific training for the laboratory person(s), specific training for the pharmacy personnel, specific training for the clinicians, specific training for the counsellors etc. These will be organized over the next 2 weeks.


Second round training for research staff from PREGART trial sites in Ethiopia

PREGART Project has conducted the second round training on Good clinical Practice (GCP), Good clinical Laboratory Practice (GCLP) and Protocol familiarization for research staff from different PREGART trial sites in Ethiopia from March 08 to March 11, 2020 at Bishoftu, 45 kilometers South of Addis Ababa. Forty-five (45) trainees including obstetricians, gynecologists, pediatrician, clinical nurses, laboratory technologists, pharmacists, and adherence supporters participated in this training. At the end of the training, selected trainees with different responsibilities in the clinical trial demonstrated the clinical flow of the trial as a role-play. Trained HIV positive adherence support mothers were involved as trial participants in this role-play. The activity plan and other issues relevant for the successful implementation of the project has also been discussed. The project has trained and certified a total of eighty (80), including the first round, research staffs with different trial role form ten research site hospitals.

This will help the project to have adequate human resources throughout the trial implementation despite there is staffs turnover.

 


First round training for research staff from PREGART trial sites in Ethiopia

PREGART Project has conducted the first round training on Good clinical Practice (GCP), Good clinical Laboratory Practice (GCLP) and Protocol familiarization for research staff from different PREGART trial sites in Ethiopia from February 28 to March 02, 2020 at Bishoftu, 45 kilometres south of Addis Ababa. Thirty-five trainees including obstetricians/gynecologists, pediatrician, clinical nurses, laboratory technologists, pharmacists, adherence supporters, project coordinators and data manager participated in this training. At the end of the training, selected trainees with different responsibilities in the clinical trial demonstrated the clinical flow of the trial as a role-play. Trained HIV positive adherence support mothers were involved as trial participants in this role-play. The activity plan and other issues relevant for the successful implementation of the project has also been discussed.

 

 


PREGART presentation in Uganda

After the official launch in Ethiopia in September, the PREGART clinical trial was also officially presented in Uganda on 23 January 2020 at the Protea Hotel Marriot in Kampala.
The launch was preceded by an investigators' meeting and was followed by a site visit at one of the facilities where the trial will be implemented, the Mildmay Hospital Uganda.

Read and download programs and speakers' presentations:

 

Visit in a Lab

 

 

Meeting in Uganda


Kick-off meeting

PREGART project kick-off and investigators meeting in Addis Abeba on 14-16 September 2019.

Read and download the Report:

Read and download programs and speakers’ presentations:

See the media gallery and know the  members of the project. Watch the video presentation of the project.

PHOTOGALLERY


PREGART partners

The trial will be implemented in Ethiopia and Uganda by research teams based at Karolinska Institute (KI), Stockholm, Sweden; Istituto Superiore di Sanità (ISS), Rome, Italy; Hawassa University (HU), Hawassa, Ethiopia and Makerere University (MU), Kampala, Uganda – PREGART Consortium will be established by the four Universities. Know PREGART partners.


PREGART starts!

Safety and efficacy of Dolutegravir and EFV400 for pregnant and breastfeeding women: a randomized non-inferiority clinical trial. Expected outcomes include generating scientific evidence to support the use of EFV400 and DTG for pregnant and breastfeeding women, generating evidence on the safety of EFV400 and DTG for pregnant and breastfeeding women. PK/PD/PGx data will also be generated to further support the dosing of EFV and DTG during pregnancy and breastfeeding. Read project presentation and work packages.